Immunoassay Development and Manufacturing

ELISA & LFIA Tests

Immunoassays allow the detection and quantification of various targets in different types of samples. They are based on the  recognition between one or more antibodies and an antigen.

BIOTEM proposes contracts with guaranteed results for the development and validation of ELISA and LFIA tests (rapid tests, Lateral Flow Immunoassay).

The company offers also a fully integrated, equipped and scalable manufacturing platform for the industrial production of kits.

Thanks to the ISO 13485:2016 certification (see Quality Policy), the tests developed by BIOTEM can be used as in vitro diagnostic medical devices (IVD) and in all types of applications:

Human health, Animal health, Industrial quality control, Agriculture, Biosecurity, Drugs, Environment, etc.

1. Project specifications

For each project, our team explores with the client the challenges of the project and defines the specifications. At the end of this phase BIOTEM recommends one or several strategies for the development.

  • Analyte to be detected/ quantified
  • Type of test: LFIA (rapid test) or ELISA
  • Performances of the test
  • Matrix (blood, urine, saliva, etc.)
  • Available material (antibodies, antigens, samples, etc.)

2. Feasibility

The feasibility study is the first experimental step of the development process during which BIOTEM evaluates and selects the best components available (antibodies, antigens, membranes, conjugates, etc.). The company has expertise in the high quality generation antibodies (mice / rats, rabbits, etc.), proprietary technologies for antigen conjugation and optimized tracers. BIOTEM has the ability to integrate, from the early stages of antibody development, specific screenings to identify the best functional antibodies in the final format. BIOTEM initiates the development of different prototypes according to the development strategy previously defined.

Finally, BIOTEM proposes a development contract with guaranteed results or resource commitments (see below).

3. Optimization

BIOTEM optimizes prototypes initially developed during the feasibility study. During this phase several validations of the prototypes are undertaken in order to ensure that the development is in line with the project specifications.

4. Validation

BIOTEM and the client jointly carry the formal evaluation (laboratory or field trials) of the performance and the several characteristics of the test. This validation phase is performed to meet the client’s specifications :

  • Limit of detection
  • Linearity / Parallelism
  • Specificity
  • Precision
  • Inter- and Intra-assay reproducibility
  • Robustness
  • Stability studies of the test and its components

5. Production & Industrialization

To complete the project, BIOTEM proposes several options to the client :

  • Transfer of technology to the client or client’s manufacturer
  • Industrialization and batch production

BIOTEM offers a fully integrated and scalable manufacturing platform for the industrial production ELISA and Lateral Flow (strips/ cassettes) kits. A semi-automated platform based in France, certified ISO 13485:2016 for IVD with state-of-the-art equipment, allows a perfect adaptation to all needs in terms of capacity and lead times.

  • Flexible and Robust Process
  • Fully Integrated Manufacturing Platform based in France (Apprieu)
  • Personalized Assistance in all steps of the production
  • Dedicated Equipment and Teams
  • Small, Medium and Large Scale Production (24/7)
  • Quality Certifications

How BIOTEM designs and develops

the immunoassays ?

Presentation of

Lateral Flow tests (immunochromatography system assays) are based on the migration of nano or micro particles on strips for analytes detection in several areas. These tests, strips or cassettes (example: the pregnancy test), are also called Point of Care tests (POCT) and are widely used in first-line emergency tests performed at the patient’s bedside or directly in the field.

Development and Industrial Production:

  • Mastersheet/ Card Lamination
  • Biological Preparation (antibody conjugated to tracers, buffers, etc.)
  • Component Preparation
  • Spraying, Dispensing, Drying and Cutting
  • Kit Assembly, Packaging and Storage (strips & cassettes)
  • Capacity: 200k to 1,000k tests per month

Results

Both the client and BIOTEM define together a contract containing :

  • The criteria or the success of the project
  • Success criteria definition
  • Success fee” clause (payment in case of success only)

Guaranteed results contracts are the best commitments that BIOTEM is proud to propose to its clients which reflects BIOTEM’s excellence..

Resources

In occasional cases, it will not be feasible to offer results commitments (mostly when success criteria cannot be clearly defined). The test development will then consist of a series of intermediary phases (each with a set duration) during which BIOTEM allocates especially dedicated resources.

  • Intermediary phases reports including the results
  • Development work suggestions.

After a discussion with BIOTEM, the client decides on the continuation of the project (GO/no GO).

Presentation of

Principally used for R&D and for in vitro diagnostic, ELISA tests (plates) are enzymatic immunoassays for the multiplexe detection and quantification of analytes in equipped laboratories.

Development and Industrial Production:

  • Biological Preparation (antibody conjugation, buffers, etc.)
  • Component Preparation
  • Coating & Drying of Plates
  • Kit Assembly, Packaging and Storage
  • Capacity: 5k to 50k tests

Results

Both the client and BIOTEM define together a contract containing :

  • Les critères de réussite du projet
  • Success criteria definition
  • Success fee” clause (payment in case of success only)

Guaranteed results contracts are the best commitments that BIOTEM is proud to propose to its clients which reflects BIOTEM’s excellence.

Resources

In occasional cases, it will not be feasible to offer results commitments (mostly when success criteria cannot be clearly defined). The test development will then consist of a series of intermediary phases (each with a set duration) during which BIOTEM allocates especially dedicated resources.

  • Intermediary phases reports including the results
  • Development work suggestions.

After a discussion with BIOTEM, the client decides on the continuation of the project (GO/no GO).

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